0 Ratings
ID

17219

Description

A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00517283

Link

https://clinicaltrials.gov/show/NCT00517283

Keywords

Versions (1)
  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Type 2 Diabetes Mellitus NCT00517283

    English

    Eligibility Type 2 Diabetes Mellitus NCT00517283

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects with at least 1 year history of type 2 diabetes mellitus.
    Description

    Type 2 diabetes mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening hba1c ≥7.0% and ≤10.0%.
    Description

    HbA1C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202054
    between the body mass index (bmi) of 19 kg/m2 and 40 kg/m2, inclusive.
    Description

    BMI

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
    Description

    Investigational Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
    Description

    drugs affecting gastrointestinal motility

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0017184
    subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
    Description

    Concomitant medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
    Description

    Insulin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021641
    blood donation of more than 500 ml in the last 3 months of screening or any blood donation within the last month.
    Description

    blood donation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005794
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    Similar models

    Eligibility Type 2 Diabetes Mellitus NCT00517283

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Type 2 diabetes mellitus
    Item
    subjects with at least 1 year history of type 2 diabetes mellitus.
    boolean
    C0011860 (UMLS CUI [1])
    HbA1C
    Item
    subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening hba1c ≥7.0% and ≤10.0%.
    boolean
    C0202054 (UMLS CUI [1])
    BMI
    Item
    between the body mass index (bmi) of 19 kg/m2 and 40 kg/m2, inclusive.
    boolean
    C1305855 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Investigational Drugs
    Item
    within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
    boolean
    C0013230 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
    boolean
    C2348568 (UMLS CUI [1])
    drugs affecting gastrointestinal motility
    Item
    subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0017184 (UMLS CUI [1,3])
    Concomitant medication
    Item
    subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
    boolean
    C2347852 (UMLS CUI [1])
    Insulin
    Item
    subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
    boolean
    C0021641 (UMLS CUI [1])
    blood donation
    Item
    blood donation of more than 500 ml in the last 3 months of screening or any blood donation within the last month.
    boolean
    C0005794 (UMLS CUI [1])
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